Clinical Evaluation of a Novel Tablet Formulation of Traditional Thai Polyherbal Medicine Named Nawametho in Comparison with Its Decoction in the Treatment of Hyperlipidemia

Abstract

In the traditional medical system in Thailand, medicinal plants and polyherbal medicines have been prescribed as lipid-lowering agents, including Nawametho decoction. This polyherbal formulation is described in the Worayokasan scripture. It consists of nine medicinal plants (Aegle marmelos (L.), Carthamus tinctorius L., Hibiscus sabdariffa Linn., Phyllanthus emblica L., Piper longum L., Piper nigrum L., Terminalia bellirica (Gaertn.) Roxb., Terminalia chebula Retz., and Zingiber officinale Roscoe). Apart from its utilization in Thai traditional medicine, there is a lack of evidence supporting its use. This research work thereby aims to formulate and evaluate the tablet containing Nawametho decoction. The feasibility of Nawametho decoction and NawaTab for patients with borderline hyperlipidemia was additionally examined using a prospective, open-label, randomized, parallel-group design. The dry granulation technique was employed to formulate the polyherbal tablets. The tablets were developed using the spray-dried Nawametho decoction as the active ingredient in addition to other excipients. The chosen formulation, the FB (NawaTab), consisted of 385 milligrams of the extract, 12% w/w of a diluent (lactose), 8% w/w of a lubricant (magnesium stearate), 5% w/w of a disintegrant (microcrystalline cellulose), and 5% w/w of an anti-adherent (talcum). Their hardness, friability, and disintegration time were 4.4 ± 0.32 kg, 0.05 ± 0.02%, and 4.60 ± 0.05 min, respectively. Accelerated stability study results revealed that NawaTab was stable for six months at 40°C/75% RH and 25°C/60% RH. Even though taking NawaTabs (500 mg twice daily) for eight consecutive weeks was unable to improve the lipid profile of the patients, the administration of Nawametho decoction (30 mL twice daily) was associated with a significant decrease in serum triglycerides of the patients. The results show that the dry granulation technique is suitable for the formulation of NawaTab based on the tablet evaluation. Furthermore, the triglyceride-lowering effect of Nawametho decoction was reported for the first time.